About this trial
The aim of this study is preliminary exploration of the effectiveness and duration of autologous decidual-like NK cells therapy in improving uterine NK cells dysfunction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
abnormal uterine NK cell function;
have one of the following medical history: unexplained recurrent spontaneous abortions (≥2 spontaneous abortions, including biochemical pregnancy), repeated implantation failure (failure of implantation of good-quality embryos in at least two IVF cycles), unexplained infertility, early-onset severe gestational hypertension or early-onset fetal growth restriction;
have clear fertility desires;
normal ovarian function or with frozen embryos;
Disqualifiers
using progesterone receptor modulator;
chromosomal karyotype abnormalities in one spouse;
severe endometriosis, uterine fibroids affecting the shape of the uterine cavity or the size of the whole uterus more than 2 and a half months of pregnancy, uterine malformation, uterine adhesion or thin endometrium;
uncontrolled autoimmune diseases;
Trial design
Single group
Treatments tested in this trial
autologous decidual-like NK cells
Biological/Vaccineintrauterine infusion
Treatment groups
Trial outcomes
Primary outcomes
Improvement rate of NK cells
Improvement rate of NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells
Secondary outcomes
Duration of improvement in NK cells
Duration of improvement in NK cells in menstrual blood of patients after intrauterine infusion of autologous decidual like NK cells
Clinical pregnancy
Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity
Ongoing pregnancy
At least 12 weeks of pregnancy, ultrasound indicates that the fetus has cardiac activity and the size of the fetus matches the gestational age
Live birth
Delivery of any number of neonates born at 26 or more weeks' gestation with signs of life
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
The University of Science and Technology of China
Collaborator